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Home-Based Exercise Tele-Rehabilitation After COVID-19 (BOOST)

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VA Office of Research and Development

Status

Enrolling

Conditions

Post SARS-CoV2 (COVID-19)

Treatments

Other: Tele-exercise

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT05425264
F3639-R

Details and patient eligibility

About

The Coronavirus Disease 2019 (COVID-19) pandemic has resulted in catastrophic infections and fatalities across the nation. Many older Veterans with comorbidities are especially vulnerable to complications and poor recovery. This award will investigate the effect of a novel, home-based, supervised, group exercise tele-rehabilitation in Veterans recovered from COVID-19 on cardiopulmonary and physical function.

Full description

There is an urgent need to understand the lasting impact of COVID-19 on the cardiopulmonary system to improve physical function and prevent long-lasting disability. Pertinent knowledge gaps regarding the post-recovery physiology driving any impairments need to be addressed to improve the quality of life in Veterans with prior SARS-CoV-2 infection. Further, it is important to devise successful rehabilitation strategies that can be safely conducted in a Veteran's home. Hence, the investigators propose to utilize VA Video Connect to deliver a home based, supervised group exercise program to Veteran COVID-19 survivors. The objective of this exercise trial is to determine the influence of COVID-19 on cardiorespiratory fitness, pulmonary and physical function and to investigate the effect of a home-based exercise tele-rehabilitation on these outcomes. The study design includes rural and urban sites and investigators with a history of VA rehabilitation collaboration. Moreover, the investigators will explore healthcare disparities related to COVID-19 which are associated with functional decline and may affect sustainability of exercise rehabilitation strategies deployed, if necessary, under social distancing restrictions.

Enrollment

80 estimated patients

Sex

All

Ages

50 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Veteran
  • documented COVID-19 > 90 days ago
  • diagnosis of 2 of following conditions: hypertension, diabetes, cardiovascular disease, chronic kidney disease, chronic obstructive pulmonary disease OR 1 condition and BMI > 30 kg/m2

Exclusion criteria

  • myocardial infarction (within 3 months)
  • exertional or unstable angina (chest pain that limits activity)
  • severe congestive heart failure (EF < 20% in last year or NYHA Classification III or IV)
  • uncontrolled hypertension (SBP >180 &/or DBP > 110 mm Hg at screening)
  • screening EKG with ischemia, complex arrhythmia, or high-grade block (per Minnesota Code)
  • poorly controlled diabetes mellitus (FBS>200 mg/dl, RBS > 299 mg/dl, or HbA1C > 10)
  • treatment for cancer except skin cancer (within 3 months)
  • peripheral vascular disease with claudication
  • severe arthritis limiting ambulation
  • neurologic disease limiting ambulation (weakness requiring assist device; severe neuropathy)
  • end stage liver disease (decompensated liver disease)
  • End stage renal failure (dialysis)
  • severe pulmonary disease (home O2, admission for dyspnea or pneumonia within 1 month)
  • high fall risk (history of falls, bone fracture)
  • dementia (based on Evaluation to Consent)
  • signs or symptoms of any medical comorbidity that would preclude exercise testing or training
  • exercises on routine basis (structured aerobic exercise > 3 time per week)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

80 participants in 1 patient group

Tele-exercise
Experimental group
Description:
Exercise training 2x/week at home. Sessions include circuit exercises of aerobic and resistive training stations which are led remotely.
Treatment:
Other: Tele-exercise

Trial contacts and locations

1

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Central trial contact

Alice S Ryan, PhD

Data sourced from clinicaltrials.gov

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